MONTELUKAST RANBAXY 4 MG CHEWABLE TABLETS

Transcript

Montelukast
4 mg chewable tablets
Montelukast

Read all of this leaflet carefully before you start
taking this medicine because it contains
important information for you.
- Keep this leaflet. You may need to read it
again.
- If you have any further questions, ask your
doctor or pharmacist.
- This medicine has been prescribed for you
only. Do not pass it on to others. It may harm
them, even if their signs of illness are the same
as yours.
- If you get any side effects, talk to your doctor or
pharmacist. This includes any possible side
effects not listed in this leaflet. See section 4.
What is in this leaflet
1. What Montelukast 4 mg chewable tablets are
and what they are used for
2. What you need to know before you take
Montelukast 4 mg chewable tablets
3. How to take Montelukast 4 mg chewable
tablets
4. Possible side effects
5. How to store Montelukast 4 mg chewable
tablets
6. Contents of the pack and other information
1. What Montelukast 4 mg chewable tablets
are and what they are used for
Montelukast 4 mg chewable tablets are a
leukotriene receptor antagonist that blocks
substances called leukotrienes.
Leukotrienes cause narrowing and swelling of
airways in your lungs. By blocking leukotrienes,
this medicine improves asthma symptoms and
helps control asthma.
Your doctor has prescribed this medicine to treat
your child's asthma, preventing asthma
symptoms during the day and night.
 This medicine is used for the treatment of 2 to 5
year old patients who are not adequately
controlled on their medication and need
additional therapy.
 This medicine may also be used as an
alternative treatment to inhaled corticosteroids
for 2 to 5 year old patients who have not
recently taken oral corticosteroids for their
asthma and have shown that they are unable to
use inhaled corticosteroids.
 This medicine also helps prevent the narrowing
of airways triggered by exercise for patients 2
years of age and older.
Your doctor will determine how these tablets
should be used depending on the symptoms and
severity of your child's asthma.
What is asthma?
Asthma is a long-term disease.
Asthma includes:
• difficulty breathing because of narrowed
airways. This narrowing of airways worsens
and improves in response to various
conditions.
• sensitive airways that react to many things,
such as cigarette smoke, pollen, cold air, or
exercise.
• swelling (inflammation) in the lining of the
airways. Symptoms of asthma include:
Coughing, wheezing, and chest tightness.
2. What you need to know before you take
Montelukast 4 mg chewable tablets
Tell your doctor about any medical problems or
allergies your child has now or has had.
Do not give Montelukast 4 mg chewable
tablets to your child if he/she
• is allergic to montelukast or any of the other
ingredients of this medicine (listed in section 6).
Warnings and precautions
Talk to your doctor or pharmacist before giving
Montelukast 4 mg chewable tablets
• If your child's asthma or breathing gets worse,
tell your doctor immediately.
• This oral medicine is not meant to treat acute
asthma attacks. If an attack occurs, follow the

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instructions your doctor has given you for your
child. Always have your child's inhaled rescue
medicine for asthma attacks with you.
It is important that your child take all asthma
medications prescribed by your doctor.
This medicine should not be used instead of
other asthma medications your doctor has
prescribed for your child.
If your child is on anti-asthma medicines, be
aware that if he/she develops a combination of
symptoms such as flu-like illness, pins and
needles or numbness of arms or legs,
worsening of pulmonary symptoms, and/or
rash, you should consult your doctor.
Your child should not take aspirin
(acetylsalicylic acid) or anti-inflammatory
medicines (also known as non-steroidal antiinflammatory drugs or NSAIDs) if they make
his/her asthma worse.

Children and adolescents
For children 2 to 5 years old, Montelukast 4 mg
chewable tablets are available.
For children 6 to 14 years old, Montelukast 5 mg
chewable tablets are available.
The 4 mg chewable tablets are not recommended
in children below 2 years of age.
Other medicines and Montelukast 4 mg
chewable tablets
Tell your doctor or pharmacist if your child is
taking, has recently taken or might take any other
medicines.
Some medicines may affect how Montelukast 4
mg chewable tablets work, or Montelukast 4 mg
chewable tablets may affect how your child's other
medicines work.
Tell your doctor if your child is taking the following
medicines before starting Montelukast 4 mg
chewable tablets:
 phenobarbital (used for treatment of epilepsy)
 phenytoin (used for treatment of epilepsy)
 rifampicin (used to treat tuberculosis and some
other infections)
 gemfibrozil (used for treatment of high lipid
levels in plasma)
Montelukast 4 mg chewable tablets with food
and drink
These tablets should not be taken immediately
with food; they should be taken atleast 1 hour
before or two hours after food.
Pregnancy and breast-feeding
This subsection is not applicable for the
Montelukast 4 mg chewable tablets since they are
intended for use in children 2 to 5 years of age,
however the following information is relevant to
the active ingredient, montelukast.
Use in pregnancy
Women who are pregnant or intend to become
pregnant should consult their doctor before taking
this medicine. Your doctor will assess whether you
can take this tablet during this time.
Use in breast-feeding
It is not known if this medicine appears in breast
milk. You should consult your doctor before taking
this tablet, if you are breast-feeding or intend to
breast feed.
Driving and using machines
This subsection is not applicable for the
Montelukast 4 mg chewable tablets since they are
intended for use in children 2 to 5 years of age;
however the following information is relevant to
the active ingredient, montelukast.
This medicine is not expected to affect your ability
to drive a car or operate machinery.
However, individual responses to medication may
vary. Certain side effects (such as dizziness and
drowsiness) that have been reported with this
medicine may affect some patients' ability to drive
or operate machinery.
Montelukast 4 mg chewable tablets contains
aspartame
Aspartame is a source of phenylalanine. If your
child has phenylketonuria (a rare, hereditary
disorder of the metabolism) you should take into

account that each tablet contains phenylalanine
(equivalent to 0.674 mg phenylalanine per 4 mg
chewable tablet).
3. How to take Montelukast 4 mg chewable
tablets
Always give this medicine exactly as your doctor
or pharmacist has told you. Check with your
doctor or pharmacist if you are not sure.
• This medicine is to be given to a child under
adult supervision. For children who have
problems consuming a chewable tablet, an oral
granule formulation is available.
• Your child should take only one tablet of
Montelukast 4 mg chewable tablets once a day
as prescribed by your doctor.
• It should be taken even when your child has no
symptoms or if he/she has an acute asthma
attack.
• To be taken by mouth
For children 2 to 5 years of age:
One Montelukast 4 mg chewable tablet daily to be
taken in the evening. This tablet should not be
taken immediately with food; it should be taken at
least 1 hour before or 2 hours after food.
If your child is taking this medicine, be sure that
he/she does not take any other medicines that
contain the same active ingredient, montelukast.
If your child takes more Montelukast 4 mg
chewable tablets than he/she should
Contact your child's doctor immediately for
advice. There were no side effects reported in the
majority of over dose reports. The most frequently
occurring symptoms reported with over dose in
adults and children included abdominal pain,
sleepiness, thirst, headache, vomiting, and
hyperactivity.
If you forget to give Montelukast 4 mg
chewable tablets to your child
Try to give this medicine as prescribed. However,
if your child misses a dose, just resume the usual
schedule of one tablet once daily. Do not give a
double dose to make up for a forgotten dose.
If your child stops taking Montelukast 4 mg
chewable tablets
This medicine can treat your child's asthma only if
your child continues taking it.
It is important for your child to continue taking
these tablets for as long as your doctor
prescribes. It will help control your child's asthma.
If you have any further questions on the use of this
medicine, ask your child's doctor or pharmacist.
4. Possible side effects
Like all medicines, this medicine can cause side
effects, although not everybody gets them.
Serious side effects
If your child experiences any of the following, stop
giving the medicine and tell your doctor
immediately or go to the casualty department of
your nearest hospital.
• Allergic reactions: If your child have allergic
reactions, stop having this medicine and see a
doctor straight away. You may need urgent
medical treatment. The signs may include
rashes, swelling of the face, lips, tongue, and/or
throat which may cause difficulty in breathing or
swallowing.
• Behaviour and mood related changes:
Suicidal thoughts and actions.
• Churg-Strauss syndrome: Symptoms
include flu-like illness, pins and needles or
numbness of arms and legs, worsening of
pulmonary symptoms and/or rash.
Other side effects
In clinical studies with Montelukast 4 mg
chewable tablets, the commonly reported side
effects (occurring in at least 1 of 100 patients and
less than 1in 10 paediatric patients treated)
thought to be related to this medicine were:
 abdominal pain
 thirst
Additionally, the following side effect was reported
in clinical studies with Montelukast 10 mg film
coated tablets and 5 mg chewable tablets:
 headache

Common: may affect up to 1 in 10 people
 diarrhea, nausea, vomiting
 changes in liver function test
 rash
 fever
Uncommon: may affect up to 1 in 100 people
 dream abnormalities, including nightmares,
trouble sleeping, sleep walking, irritability,
feeling anxious, restlessness, agitation
including aggressive behaviour or hostility,
depression
 dizziness, drowsiness, pins and needles/
numbness, seizure
 nose bleed
 dry mouth, indigestion
 bruising, itching, hives
 joint or muscle pain, muscle cramps
 tiredness, feeling unwell, swelling
Rare: may affect up to 1 in 1,000 people
 increased bleeding tendency
 tremor
 palpitations
Very rare: may affect up to 1 in 10,000 people
 hallucinations, disorientation
 hepatitis (inflammation of the liver)
 tender red lumps under the skin most
commonly on your shins (erythema nodosum),
severe skin reaction (erythema multiforme) that
may occur without warning
Reporting of side effects
If your child gets any side effects, talk to your
child's doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. You
can also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard.
By reporting side effects you can help provide
more information on the safety of this medicine.
5. How to store Montelukast 4 mg chewable
tablets
Keep this medicine out of the sight and reach of
children.
Do not use this medicine after the date which is
stated on the carton after EXP.The expiry date
refers to the last day of that month.
Store in the original package in order to protect
from light and moisture.
Do not throw away any medicines via wastewater
or household waste. Ask your pharmacist how to
throw away medicines you no longer use. These
measures will help protect the environment.
6. Contents of the pack and other information
What Montelukast 4 mg chewable tablets
contain
• The active substance is montelukast. Each
tablet contains montelukast sodium which
corresponds to 4 mg of montelukast.
• The other ingredients are: Mannitol,
microcrystalline cellulose, low substituted
hydroxypropyl cellulose, red iron oxide (E172),
croscarmellose sodium, cherry flavour
(Flavourings, Maize Maltodextrin, Moisture),
aspartame (E951), magnesium stearate.
What Montelukast 4 mg chewable tablets look
like and contents of the pack
Montelukast 4 mg chewable tablets are Pink to
red coloured, mottled, oval shaped, biconvex
tablet with“MT4” debossed on one side and plain
on the otherside.
Blisters in package of 28 tablets.
Marketing Authorisation Holder and
Manufacturer
Marketing Authorisation Holder:
Ranbaxy UK Ltd
Building 4 Chiswick Park,
566 Chiswick High Road
London, W4 5YE
United Kingdom
Manufacturers:
Ranbaxy Ireland Ltd
Spafield, Cork Road
Cashel
Co. Tipperary
Ireland

These were usually mild and occurred at a greater
frequency in patients treated with Montelukast
than placebo (a pill containing no medication).

Terapia SA
124 Fabricii Street
400 632 ClujNapoca
Romania

Very common: may affect more than 1 in 10 people
 upper respiratory infection

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.